N/A
N=1,063
GLORIA-AF Registry Program (Phase I)
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01428765 ↗Enrolled (actual)
1,063
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: CHADS2 Score — 102; 386; 575 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CHADS2 Score |
102; 386; 575 | — |
| PRIMARY CHA2DS2-VASc Score |
0; 226; 837 | — |
| PRIMARY HAS-BLED Risk Score |
860; 121; 82 | — |
| PRIMARY Antithrombotic Treatment Choice at Baseline |
215; 349; 443; 36; 20 | — |
| PRIMARY Gender |
486; 577 | — |
| PRIMARY Age Group |
382; 314; 367 | — |
| PRIMARY Medical History |
110; 256; 256; 795; 240 | — |
| PRIMARY Concomitant Medication |
739; 395 | — |
Summary
This study constitutes Phase I of the Registry Program. The main objective of this study is to characterize the newly diagnosed non-valvular AF patient population at risk for stroke and the selection of antithrombotic treatment for stroke prevention in a real-world setting before dabigatran etexilate is approved for the prevention of strokes and systemic emboli in patients with non-valvular AF in different regions of the world.
Eligibility Criteria
Inclusion criteria
- Patients newly diagnosed with non-valvular atrial fibrillation at risk for stroke.
Exclusion criteria
- Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention;
- Patients who have received more than 60 days of oral anticoagulant treatment (vitamin K antagonist) (VKA) in their lifetime;
- Atrial fibrillation (AF) with a generally reversible cause;
- Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (VKAs) is indicated
Data sourced from ClinicalTrials.gov (NCT01428765). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.